1. Field of the Invention
The present invention relates generally to urine collection devices and, more particularly, to a non-invasive female external urine collection device providing an input to an external catheter.
2. Description of the Prior Art
Hospitalized patients are often unable, and typically as a consequence of a post-operative condition, to control their urinary functions. Also, those who are able to control such functions may be physically unable to use a urinal or bedpan. Therefore, patients in either of said categories are fitted with urine collection devices known as catheters. Male patients are provided with internal or urethral catheters for as long as urine volumes need to be monitored, after which time, external catheters are used. Women, however, typically continue to keep internal catheters for as long as they remain unable to use normal facilities and, as a result thereof, frequently develop severe bladder or urinary track (UTI) infections. Such UTIs are typically nosocomial infections which, it has been determined, affect approximately five percent of all hospitalized individuals. For such patients, nosocomial infections can lead to pain, disability, a longer hospital stay, or worse. In the United States alone, the treatment of nosocomial infections add billions of dollars each year to the cost of healthcare. Further, it has been determined that UTIs account for forty percent of all nosocomial infections. Accordingly, the use of internal or indwelling urethral catheter account for a large proportion of all hospital-associated infections which occur. Since a nurse, or nursing assistant, typically does not have authority to determine whether or not a patient should use a urinary catheter, the issue then becomes one of which type of catheter can be used to minimize nosocomial and other urinary track infections. It has, thereby been determined that the instance of UTIs can be reduced where an external catheter can be used in lieu of an indwelling device. However, few such female external collection devices have appeared in the art, none of which have afforded an entirely satisfactory result.
Examples of such devices appear in U.S. Pat. No. 3,601,125 to Moss; U.S. Pat. No. 4,233,978 to Hickey; U.S. Pat. No. 4,563,183 to Barrodale; and U.S. Pat. No. 4,615,692 to Giacalone. Within this limited prior art, few patents suggest a unit having a projection or element adapted for insertion into the vagina itself, these comprising U.S. Pat. No. 3,776,235 to Ratcliffe; U.S. Pat. No. 4,194,308 to Anderson; U.S. Pat. No. 4,198,979 to Cooney; said U.S Pat. No. 4,563,183; and said U.S. Pat. No. 4,615,692.
In the case of said U.S Pat. Nos. 4,563,183 and 4,4,615,692, a flexible inflatable bladder is inserted into the vagina, thereby reducing the mechanical integrity of the entire structure. Another shortcoming of devices such as Ratcliffe and Anderson is that they provide or permit communication of some urine to the vagina which in itself, can increase the likelihood of infection, or are not anatomically compatible with the vagina. Other prior art tends to stretch or cause tissue damage in the area of the labia minora. Thus, there exists a continuing need for improved devices and methods for the drainage of urine from the urethra of women having little or no control of release of urine, this as a result of either a chronic or a particular post-operative condition. Such a device would, ideally, enable free movement of ambulatory women and, as well, reduce the chance of infection while improving the chance of a successful treatment of any infection that might occur. The requirements of an adequate female external catheter are therefore that of stability upon the person of the user and effective confinement of the expelled urine within a minimal area about the urethra to thereby minimize the possibility of communication of urine to other external female organs within the area of the urethra. These objectives, if achieved, will reduce the otherwise serious risk of infection of the bladder, urethra and/or vagina which, as above noted, has taken a serious role, particularly as a result of said nosocomial infections.
The instant invention relates to a female external catheter device, defined by a ladle-like body including a hollow elongate neck having a hollow bulbous nob integrally dependent from a distal end of said neck, an axis of elongation of said neck also defining a common axis of substantial radial symmetry of both said neck and nob. The device also includes an elongate hollow cup, integrally dependent from a proximal end of said neck, and having an axis of elongation generally normal to said neck axis, said cup defining a U-shaped cross-section within a plane transverse to a plane of symmetry of said device defined by said axes of elongation of said neck and said cup. Sidewalls of said cup are sized for intra-labial placement and, thereby, surround the urethral opening of a female user. Said cup also defines a transverse interior dimension in a range of about two to about four centimeters and a greatest linear dimension along said plane of symmetry of between about six and about ten centimeters. The device further includes a catheter drain nozzle including a central channel thereof in fluid communication with a channel of said neck and a lower interior surface of said cup. The fluid channel of said nozzle is, when in use, preferably in alignment with the gravity vector. Accordingly, said nob of said neck will upon insertion into the vaginal opening, comfortably and securely engage the inner sphincter muscles thereof, thus securing said device both within the vagina and upon the intra-labial region in a substantially fluid-tight manner. The apertured hollow nob and hollow neck of the device provide for proper fluid venting of the vagina, thus affording a channel of fluid discharge to the nozzle, and to eliminate urine backflow into the vagina.
It is therefore an object of the invention to provide a female external catheter device that overcomes the shortcomings of the prior art as set forth above.
It more specific is an object to provide a female external catheter means that provides for isolation of the urethral and vaginal openings, and which is invasive only as to the vagina for purposes of stabilization of the device, and fluid drainage of the vagina.
It is a further object of the invention to provide a female external catheter which provides for collection of substantially all urine passed by the patient but which minimizes the area of external female organs that are contacted by urine which is thereby collected.
It is a yet further object to provide a female external catheter device that can be effectively employed by walking, standing, seated, as well as reclining or prone patients, and which is of limited bulk to thereby enhance comfort to the patient. It is a still further object of the invention to provide a female external catheter device that is easy to apply and which, in many patients, may be self-applied.
It is a yet further object to provide such an external catheter device that is compatible with pre-existing drainage and collection means of types that are common in hospitals.
It is another object of the invention to provide a female external catheter device which will reduce the risk of urinary tract associated infections.
The above and yet other objects and advantages of the present invention will become apparent from the hereinafter set forth Brief Description of the Drawings, Detailed Description of the Invention and Claims appended herewith.